Cleared Traditional

K010738 - CANNULATED PLUS SCREW SYSTEM

K010738 is an FDA 510(k) clearance for CANNULATED PLUS SCREW SYSTEM, manufactured by Orthomatrix, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K010738 · Orthomatrix, Inc. · Orthopedic device
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Aug 2001
Decision
142d
Days
Class 2
Risk

K010738 is an FDA 510(k) clearance for the CANNULATED PLUS SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Orthomatrix, Inc. (Collierville, US). The FDA issued a Cleared decision on August 1, 2001 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Orthomatrix, Inc. devices

FDA 510(k) Submission Details - K010738

510(k) Number K010738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2001
Decision Date August 01, 2001
Days to Decision 142 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 122d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 862
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K010738.
MODIFICATION TO THE I.C.O.S SCREW
K011821 · New Deal, S.A. · Sep 2001
THE SPIN SNAP-OFF SCREW
K011946 · New Deal, S.A. · Aug 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102 · Aesculap, Inc. · Aug 2001
IN-FAST BONE SCREW SYSTEM
K011910 · American Medical Systems, Inc. · Jul 2001
AUTO-DRIVE LAG SCREW SYSTEM
K010964 · Osteomed Corp. · Jul 2001
PLUS CANCELLOUS BONE SCREWS
K011719 · Plus Orthopedics · Jul 2001